Implementation of Standard Operating Procedures/ Checklists

Prof. (Col.) Dr R.N. Basu Adviser, Hospital Planning & Management at P & C Division of Medica Synergie, &

Adviser, Quality & Academics at Medica Superspecilty Hospital, Kolkata

Formerly:-

Prof & Head of the Dept of Hospital Administration at

AFMC Pune; KMC Manipal;

Visiting Prof at NIHFW, New Delhi

2

Standard Operating Procedure

• Definition

– A Standard Operating Procedure (SOP) is a set of written instructions that document a routine or repetitive activity followed by an organisation

– The development and use of SOPs are an integral part of a successful quality system

– It provides individuals with the information to perform a job properly

– It facilitates consistency in the quality and integrity of a product or end-result

3

Standard Operating Procedure

• Purpose

– SOPs detail the regularly recurring work process

– They facilitate consistency in performance

– SOPs are intended to be specific to the organisation

– It assists an organisation to maintain

• Their quality control

• Quality assurance process

– It ensures compliance with government regulations

4

Standard Operating Procedure

• Benefits

– Minimizes variation

– Promotes quality

– Consistent implementation of a process and procedure

– Permanent and temporary changes in personnel do not affect implementation of operation

– Can be used as a personnel training programme

– Minimizes opportunities for miscommunication

– Can address safety concern

5

Standard Operating Procedure

• Writing style

– To be written in a step-by step, easy-to-read format

– Information provided should be unambiguous and not complicated

– The active voice and present tense should be used

– The term “you” should not be used but implied

– The document should not be wordy, redundant or overly lengthy

– Information should be conveyed clearly and explicitly to remove any doubt as to what is required

– Adopt the style followed in your organisation, e.g., font size, line spacing, margins

6

SOP Process

• SOP Preparation

– The organisation should have a procedure in place for determining what procedures or processes need to be documented

– These SOPs should then be written by individuals

• Knowledgeable with the activity

• Familiar with the organisation’s internal structure

7

SOP Process …….

– A team approach can be followed

• In multi-tasked processes

– Where experience of a number of individuals are critical

– This facilitates “buy-in” from potential users of the SOP

• SOP should be written in sufficient detail

– This facilitates individuals with limited experience with the procedure to implement it when unsupervised

• Experience requirement for performing an activity should be noted in the section on personnel qualifications

8

SOP Review and Approval

• SOPs should be reviewed (that is validated) by one or more individuals with appropriate training and experience with the process

– It is preferable that the draft SOPs are actually tested by individuals other than the original writer before the SOPs are finalised

• The finalised SOPs should be approved as described in the organisation’s Quality Management Plan

– Generally the immediate supervisor and the organisation’s quality officer review and approve each SOP

• Signature approval indicates that an SOP has been both reviewed and approved by management

9

Frequency of Revisions and Reviews

• SOPs need to remain current to be useful

– Whenever procedures are changed SOPs should be updated and re-approved

• SOPs should also be systematically reviewed on a periodic basis, e.g., every 1-2 years

– This is to ensure that policies and procedures remain current and appropriate

– This review may even determine whether SOPs are at all needed

– The frequency of review should be indicated in the organisation’s Quality Management Plan

10

SOPs in CEmONC Facilities

• SOPs for CEmONC facilities can be two types:

– Clinical SOPs

– Supportive SOPs

• Examples of Clinical SOPs can be developed for:

– Active Management of Third Stage of Labour

– Cesarean Section

– Blood Transfusion

– Manual Removal of Placenta

– Assisted Vaginal Delivery

• Forceps delivery

• Vacuum delivery

11

SOPs in CEmONC Facilities

• Examples of Administrative / support services SOPs:

– Admission and registration procedure

– Payment of remuneration to ASHA workers

– Maintenance of equipment of Operation Theatre / Labour Room

– Maintenance of Blood Bank Refrigerator

– Sterilization of Equipment/Quality Control of sterilization

– Inventory management of drugs and consumables

– Housekeeping/cleaning and disinfection procedures in OT/LR

– Biomedical Waste Management

– Hand Hygiene

12

13

14

15

1. AIM

2. SCOPE

3. APPLICABILITY

4. PROCEDURE

1. Subheading

2. Subheading

5. GLOSSARY

6. REFERENCES

7. APPENDICES

1. Appendix 1: Appendix title

2. Appendix: Document Tracking Form

3. Appendix (Last): Appendix Change Log

16

Implementation

• It is important to realise that developing useful and effective SOPs require time and commitment from all management and employee levels.

• After development:

– Educate employee about the new SOP

– Control procedural drift

• Ensure that SOP is followed consistently over time

– Establish an evaluation and review system

• To be certain that over time all the steps of an SOP are still correct and appropriate for the procedure

17

18

Checklists • A checklist is an algorithmic listing actions to be performed in a given clinical

setting

• The goal is to ensure that no step is forgotten

• It is a simple intervention

– It has a sound theoretical basis in human factor engineering

– It plays major role in some of the most significant success in the patient safety movement

• There are two types of tasks:

– Involving schematic behaviour

– Involving attentional behaviour

• Tasks involving schematic behaviour are performed reflexively, as if in auto-pilot mode

• Tasks involving attentional behaviour requires active planning and problem solving

19

Checklists …….

• Patterns of error in these two types of behaviour are different

• Failures of schematic behaviour are called slips

– These occur due to lapses in concentration, distractions, or fatigue

• Failures of attentional behaviour are termed mistakes

– These are caused by lack of experience or insufficient training

• In health care as in other industries most errors are caused by slips rather than mistakes

• Checklists represent a simple method to reduce risk of slips

– List of steps to be followed needs to be standardized.

– It is expected that every step will be followed for every patient

• Then the checklists shall have potential to greatly reduce errors due to slips

20

Checklists …….

• Controversies

– Checklists are remarkably useful tool in improving safety

• Care needs to be taken not to overemphasize their importance

– They cannot solve every patient safety problem

– Successful implementation of a checklist requires

• Extensive preparatory work to maximize safety culture in the unit where it will be used

• Engagement of leadership in rolling out and emphasizing the importance of checklist

– Only certain types of errors can be prevented by checklists

• Errors in clinical tasks that need primarily attentional behaviour require solutions focused on training, supervision and decision support rather than standardizing behaviour

21

Safety Checklists in Emergency Obstetric Care

• Well-designed protocols can serve as convenient

reminders of best practices

• Similarly, low-tech physical checklists can be kept at

nursing station and in labour and delivery rooms

– They serve as reminders of best practices during obstetric

emergencies

– Example:

• Having a laminated set of easy-to-read protocols for:

– Post-partum haemorrhage, Eclampsia, Maternal collapse, \Shoulder dystocia etc

• Can allow a charge nurse to check to make sure all proper procedures are

being performed by the team actually administering the care to a patient in

crisis

• This way nothing important is overlooked

22

23

24

25

26

Difficulties/Challenges in Implementation

• Doctors and other Health Care Workers want to give their

best for their patients

• They are almost always well trained, hard working, highly

motivated individuals

• Even then error occasionally occurs because:

– Medicine has become highly complex

– Physicians and nurses are human beings and may not perform perfectly

all the time, with every patient

– The system in which they work are imperfectly designed

– Due to resource constraints, they are called upon to care for as many

patients as possible in limited period of time

27

Difficulties/Challenges in Implementation

• Doctors often work in ‘silos’

– Do not want their bastion to be penetrated or their actions influenced by

any externally imposed directives

• Ownership often lacks

• There is a tremendous amount of variability from one patient

to the other

– The generalized ‘cook book’ solutions given by SOPs/Checklists are

resisted

• Therefore, the SOPs should be developed with active

participation of the doctors

• Enough flexibility should be incorporated in the SOPs

28

29